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62304 does not limit your choice of sdlc or agility. You just have to be able to read it. In generally, Developing with regulatory oversight and a real QA depa
by oaiey 6y ago
62304 does not limit your choice of sdlc or agility. You just have to be able to read it.
In generally, Developing with regulatory oversight and a real QA department is just very different. The agile manifesto speaks of "working software" over "documentation". It does not speak of code. It speaks about working software. In a regulated business "working software" includes a forest worth of hopefully digital paper and the code for your customers and oversight. The paperwork is part of the output here and not part of the self inflicted documentation.
- ska 6y agoThat's a good way of putting it, but I would avoid pinning this on "regulated industry" Rather, in good engineering practice the design and process, etc. is part of the product. Regulated industries just put some expectations on what that means. This can be done well or poorly, but it's basically the intent. Don't read that the wrong way; I don't think every product benefits enough from good engineering practice to make it worthwhile - it certainly adds some friction and makes even "fast iteration" slower. On the other hand, it's absolutely the right way to approach things with high stakes for failures.